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Bard® Foley Catheter Silicone Coated 265718Recalls & reported problems

C. R. Bard, Inc. · Bard®Foley Catheter, Silicone Coated, 5cc Balloon · Class 2

All models of Bard Foley Catheter Silicone Coated (10)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
6
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741039607), received between Dec 1, 2017 and Feb 1, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Partial Blockage” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Partial Blockage2
  • Device Contaminated During Manufacture or Shipping1
  • Device Dislodged or Dislocated1
  • Failure to Infuse1
  • Material Invagination1
  • Obstruction of Flow1

Patient problems

  • No Consequences Or Impact To Patient2
  • No Clinical Signs, Symptoms or Conditions1
  • No Information1
  • No Known Impact Or Consequence To Patient1
  • Pain1
  • Unspecified Infection1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 1, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE EMERGENCY ROOM CAUSED MOLD ON SILICONE FOLEY CATHETER TO GREEN COLOR, OTHER WERE YELLOW. THE PATIENT DID NOT LIKE THE CATHETERS AND HAD PROBLEMS WITH 2 18FR 5CC, WANTED TO TRY ANOTHER SUPPLIER. IT WAS UNKNOWN IF THE DEVICE CAUSED THE INFECTION AND UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE INFECTION AT THIS TIME.

    Patient problems: Unspecified Infection

    MAUDE report 16277505 ↗
  • MalfunctionOct 26, 2022Failure to Infuse; Failure to Infuse

    IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON DID NOT EXPAND.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15673283 ↗
  • MalfunctionApr 21, 2020Partial Blockage; Obstruction of Flow; Partial Blockage

    IT WAS REPORTED THAT THE PATIENT SAID THE CATHETER WAS CLOGGING AND HE WENT TO THE HOSPITAL AND THEY GAVE HIM A 20FR.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 9980748 ↗
  • MalfunctionJul 10, 2019Material Invagination; Material Invagination

    IT WAS REPORTED THAT THE BALLOON OF THE SILICONE FOLEY CATHETER MUSHROOMED; CAUSING PAIN TO THE PATIENT. NO MEDICAL INTERVENTION REPORTED.

    Patient problems: Pain

    MAUDE report 8777875 ↗
  • MalfunctionApr 13, 2018Partial Blockage; Partial Blockage

    IT WAS REPORTED THAT THE FOLEY CATHETER WAS CLOGGING UP.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7430376 ↗
  • MalfunctionDec 1, 2017Device Dislodged or Dislocated

    PATIENT WAS IN SURGERY. A FOLEY CATHETER WAS PLACED DURING SURGERY. ONE DAY POST-OP, THE PATIENT ROLLED OVER, HEARD A "POP", AND THE FOLEY CATHETER CAME OUT. THE SURGEONS LOOKED AT THE CATHETER AND REPORTED IT HAVING A SPLIT IN IT. IT WAS SENT TO CLINICAL ENGINEERING FOR INVESTIGATION AND WILL BE RETURNED TO THE MANUFACTURER FOR FAILURE ANALYSIS. PER SITE REPORTER: THE MANUFACTURER WILL BE SENDING A RETURN KIT. THE DEVICE WILL BE RETURNED FOR FAILURE ANALYSIS.

    Patient problems: No Information

    MAUDE report 7074297 ↗

Other CATHETER, COUDE devices

All CATHETER, COUDE devices →

Sources and updates

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